Advancing TRANQUILITY and SERENITY program plans for two pivotal Phase 3 trials to expand BXCL501 market potential in acute treatment of agitation
Strengthened intellectual property portfolio for BXCL501 with grant of two new patents, in
Completed
Conference call set for 8:00 a.m. ET today
“The fundamentals of our business are strong as we look to continue advancing and expanding our agitation portfolio,” said
TRANQUILITY and SERENITY Clinical Programs
- Plans for two late-stage programs are advancing following recently announced designs of pivotal Phase 3 trials:
- TRANQUILITY In-Care trial: designed to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 for agitation associated with Alzheimer’s dementia (AAD).
- SERENITY At-Home* safety trial: designed to evaluate the safety of a 120 mcg dose of BXCL501 in the at-home setting for agitation associated with bipolar disorders or schizophrenia.
- Study protocol submitted to FDA.
IGALMI™ Post-Marketing Requirement (PMR) Study
- Study was designed to evaluate whether tolerance, tachyphylaxis, or withdrawal occur following repeat dosing of IGALMI™ following seven days of repeated treatment.
- Completed enrollment of approximately 20 patients with frequent episodes of agitation for bipolar disorders or schizophrenia in an open-label study.
- Patients self-administered 180 mcg of IGALMI for repeated agitation episodes over the treatment period.
- Initiated data cleaning to enable database lock.
Corporate Updates
IGALMI™ Commercialization
- Net revenue grew 55% in Q1 2024 over the prior quarter driven largely by volume contracting, new customer acquisition, increased utilization among existing customers, and the permanent J-Code for IGALMI that became effective
January 1, 2024 .
Patent Portfolio
The Company continues to strengthen its intellectual property portfolio with over 30 granted or allowed patents and more than 140 additional patent applications in prosecution as of
- Recently granted two new patents for BXCL501, in
Japan and theU.S. , with patent protection to 2039 and 2043, respectively. - Eight currently listed
U.S. patents for IGALMI™ in theUnited States Food and Drug Administration's (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the "Orange Book"), with two additional recently allowed patents that will be submitted for listing in the Orange Book once issued by the USPTO.
OnkosXcel Therapeutics
- Announced late-breaking abstract selected for presentation at 2024 ASCO Annual Meeting on preliminary findings from a Phase 2 investigator-sponsored trial of BXCL701 and KEYTRUDA® (pembrolizumab) in metastatic pancreatic ductal adenocarcinoma (PDAC).
First Quarter 2024 Financial Results
Net Revenue: Net revenue from IGALMI was
Research and Development (R&D) Expenses: R&D expenses were
Selling, General and Administrative (SG&A) Expenses: SG&A expenses were
Net Loss:
Cash and cash equivalents totaled
Conference Call and Webcast
*SERENITY At-Home represents the redesigned SERENITY III trial.
About IGALMI™ (dexmedetomidine) sublingual film
INDICATION
IGALMI™ (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children.
IMPORTANT SAFETY INFORMATION
IGALMI can cause serious side effects, including:
- Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint.
- Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations.
- Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI.
- Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours.
The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing.
These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects.
Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids.
Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also contact
Please see full Prescribing Information at igalmi.com.
About BXCL501
In indications other than those approved by the
About BXCL701
BXCL701 is an investigational, oral innate immune activator designed to initiate inflammation in the tumor microenvironment. Approved and experimental immunotherapies often fail to address cancers that appear “cold.” Therefore, BXCL701 is being evaluated to determine if it can render “cold” tumors “hot,” making them more detectable by the adaptive immune system and thereby facilitating the development of a strong anticancer immune response. OnkosXcel Therapeutics’ preclinical data support BXCL701’s potential synergy with both current checkpoint inhibitors and emerging immunotherapies directed to activate T-cells. BXCL701 is currently being developed as a potential therapy for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. BXCL701 has received Orphan Drug Designation from the
About
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: the Company’s planned advancement of its TRANQUILITY and SERENITY trials and the trial designs thereof; potential market opportunity for BXCL501; the potential for the results from the Company’s completed, ongoing and proposed clinical trials to support regulatory approvals for its product candidates; its ongoing strategy for IGALMI; the Company’s current patent applications; expected cash runway; . When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: [the outcome of the Company’s discussions with
Contact Information
Corporate
1.203.494.7062
ekopp@bioxceltherapeutics.com
Investor Relations
1.475.355.8462
bdoyle@bioxceltherapeutics.com
Media
1.858.717.2310
David.schull@russopartnersllc.com
1.646.942.5630
Scott.stachowiak@russopartnersllc.com
Source:
IGALMI™ is a trademark of
BT BIOXCEL THERAPEUTICS is a registered trademark of
All other trademarks are the properties of their respective owners.
Copyright © 2024, BioXcel Therapeutics, Inc. All rights reserved.
Statements of Operations | ||||||||
(Unaudited, in thousands, except per share amounts) | ||||||||
Three months ended | ||||||||
2024 | 2023 | |||||||
Revenues | ||||||||
Product revenues | $ | 582 | $ | 206 | ||||
Operating expenses | ||||||||
Cost of goods sold | 80 | 9 | ||||||
Research and development | 11,401 | 27,800 | ||||||
Selling, general and administrative | 13,264 | 23,595 | ||||||
Total operating expenses | 24,745 | 51,404 | ||||||
Loss from operations | (24,163 | ) | (51,198 | ) | ||||
Other (income) expense | ||||||||
Interest expense, net | 3,607 | 3,367 | ||||||
Interest income | (947 | ) | (2,015 | ) | ||||
Other (income) expense, net | (32 | ) | 246 | |||||
Net loss and comprehensive loss | $ | (26,791 | ) | $ | (52,796 | ) | ||
Net loss per share - basic and diluted | $ | (0.87 | ) | $ | (1.84 | ) | ||
Weighted average shares outstanding - basic and diluted | 30,868 | 28,616 | ||||||
Condensed Balance Sheets | ||||||||
(Unaudited, in thousands) | ||||||||
2024 | 2023 | |||||||
Cash and cash equivalents | $ | 74,141 | $ | 65,221 | ||||
Total assets | $ | 82,323 | $ | 73,702 | ||||
Total liabilities | $ | 154,686 | $ | 130,210 | ||||
Total stockholders' equity (deficit) | $ | (72,363 | ) | $ | (56,508 | ) | ||
Source:
2024 GlobeNewswire, Inc., source